Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children

Phase 4

Recruiting

• Conditions: Newly Diagnosed Immune Thrombocytopenia in Children, First Line Treatment
• Interventions: Drug: intravenous immunoglobulin

• Registration Number: NCT05520892
• Lead Sponsor: Fujian Medical University Union Hospital

Brief Summary

To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia, and to reduce related adverse reactions and economic burdens on the premise of ensuring the remission rate

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-28
• Study First Submitted QC: 2022-08-28
• Study First Posted: 2022-08-30
• Study Start: 2022-10-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

Subjects enrolled in this study must meet all of the following criteria:

1. Meet the diagnostic criteria of ITP and be diagnosed for the first time without treatment
2. Age > 28 days and ≤ 14 years old
3. PLT<20×109/L
4. Have signed the informed consent

Exclusion Criteria

Anyone who has any of the following conditions will not enter the clinical study:

1. Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and glucocorticoid therapy
2. Received glucocorticoid or IVIG therapy within 6 months
3. Weight > 40kg
4. Menstrual female patients
5. Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
6. Patients who have received radiotherapy and chemotherapy
7. There are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low-dose intravenous immunoglobulin	intravenous immunoglobulin	0.4g/kg.d, d1-5
high-dose intravenous immunoglobulin	intravenous immunoglobulin	1.0g/kg.d, d1-2

Primary Outcome Measures

Name	Time	Method
early response to treatment	7 days after treatment	Platelet counts after 7 days of IVIG treatment

Secondary Outcome Measures

Name	Time	Method
Economic Indicators	1 week	Calculate the total amount of IVIG used in 1 week (weight normalized)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	1 week	Incidence of Treatment-Emergent Adverse Events in 1 week

Trial Locations

Locations (1)

Children with newly dignosed ITP; 🇨🇳 Fuzhou, Fujian, China